Promega Corp. v. Life Tech

Shipment of Single Important Component to Party’s Own Foreign Manufacturing Facility Constitutes Inducement Under § 271(f)(1)

13-1011

December 15, 2014

Decision

Last Month at the Federal Circuit - January 2015

Judges: W.D. Wis., Chief Judge Crabb

[Appealed from: W.D. Wis., Chief Judge Crabb]

In Promega Corp. v. Life Technologies Corp., Nos. 13-1011,-1029,-1376 (Fed. Cir. Dec. 15, 2014), the Federal Circuit reversed the district court's finding that four asserted patents were not invalid for lack of enablement, reversed the district court's grant of JMOL of noninfringement of U.S. Patent No. RE37,984 ("the Tautz patent"), affirmed the district court's finding that certain sales by Life Technologies Corp. ("LifeTech") fell outside the scope of the cross license, vacated the jury's damages award, and remanded for a new trial on damages.

Promega Corp. ("Promega") owns U.S. Patent Nos. 5,843,660 ("the '660 patent"); 6,221,598 ("the '598 patent"); 6,479,235 ("the '235 patent"); and 7,008,771 ("the '771 patent") (collectively "the Promega patents"), and is the exclusive licensee of the Tautz patent. The Promega patents claim methods and kits for simultaneously determining alleles present in a set of short tandem repeat ("STR") loci from DNA samples. The claims of the Promega patents recite "a set of . . . loci" followed by either the transitional phrase "consisting of"—the so-called "closed loci set" claims—or "comprising"—the so-called "open loci set" claims. Slip op. at 6-7. The Tautz patent is also directed to a process for examining polymorphism in DNA samples. LifeTech manufactures genetic testing kits that provide components for carrying out a multiplex amplification of STR loci from DNA samples. Each of these kits is designed to co-amplify STR loci, including the loci listed in the asserted claims of the Promega patents as well as loci that are not listed in the claims. The kits contain a primer mix, a Taq polymerase, a PCR reaction mix, a buffer solution, and control DNA. LifeTech manufactures the Taq polymerase in the United States and ships it to a LifeTech manufacturing facility in the United Kingdom, which assembles and sells the kits worldwide.

Promega and Applied Biosystems, LLC ("Applied Biosystems"), a wholly owned subsidiary of LifeTech, entered into a cross license agreement that granted Applied Biosystems the right to use the alleged inventions in the Promega and Tautz patents for "Forensics and Human Identity Applications." Id. at 9. The cross license also limited Applied Biosystems use to, among other things, activities relating to legal proceedings.

Promega sued LifeTech for infringement of the Promega and Tautz patents, alleging that LifeTech sold STR kits not covered by the cross license. The district court granted SJ that some LifeTech sales directly infringed the Promega and Tautz patents, and rejected LifeTech's argument that the Promega patents lacked enablement and were invalid for obviousness. At trial, the jury returned a verdict of willful infringement, found that all of LifeTech's worldwide sales were attributable to infringing acts in the United States, and awarded damages to Promega. LifeTech then moved for JMOL, which the district court granted, finding that Promega failed to present sufficient evidence to sustain a jury's verdict of infringement under 35 U.S.C. § 271(a) and (f)(1). The district court vacated the finding of infringement and denied Promega's motion for reconsideration or a new trial. LifeTech and Promega both appealed.

On appeal, the Federal Circuit considered whether the Promega patents were invalid for lack of enablement. The Court explained that the "open loci set" claims encompassed not only the co-amplification of the three STR loci recited in the claims, but also the co-amplification of larger, more complex multiplex reactions, as long as the reactions included the three recited loci. The Court observed that there was "no genuine dispute that identifying STR loci multiplexes that will successfully co-amplify is a complex and unpredictable challenge," and that "undue experimentation may be required to identify a successfully co-amplifying multiplex that adds even a single new locus to an existing loci combination." Id. at 15. Because the "open loci set" claims encompassed more than just the recited loci, the Court explained that Promega had "chosen broad claim language 'at the peril of losing any claim that cannot be enabled across its full scope of coverage.'" Id. at 17 (quoting MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012)). Comparing the claims of the Promega patents to claims that had been invalidated in MagSil, the Court determined that the Promega patents' "open loci set" claims "cover the successful co-amplification of a virtually unlimited number of STR loci combinations," but that the Promega patents "would not have enabled a skilled artisan . . . to identify significantly more complicated sets of STR loci combinations that would successfully co-amplify . . . without undue experimentation." Id. at 18. Because the Promega patents did not enable a skilled artisan to practice the full breadth of the claim scope without undue experimentation, the Court held that the challenged claims of the Promega patents were invalid for lack of enablement under 35 U.S.C. § 112, ¶ 1. The Court thus reversed the district court's denial of LifeTech's motion for SJ of invalidity and vacated the district court's grant of SJ of infringement of the Promega patents.

Next, the Court turned to whether the district court properly granted JMOL of noninfringement of the Tautz patent under 35 U.S.C. § 271(f)(1), considering two aspects of § 271(f)(1). First, the Court addressed whether the phrase "to actively induce the combination" in the statute requires the involvement of a third party. After considering dictionary definitions of "induce," the plain language of the statute, and the legislative history, the Court concluded that a third party was not required to find inducement under § 271(f)(1). The Court also noted that § 271(f) was enacted to close a loophole left by the Supreme Court's decision in Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518 (1972), and that Congress chose broadening language when drafting the statute. The Court then concluded that "it is unlikely that Congress intended § 271(f)(1) to hold companies liable for shipping components overseas to third parties, but not for shipping those same components overseas to themselves or their foreign subsidiaries." Slip op. at 25-26.

The Court next considered whether the language "substantial portion of the components of a patented invention" in § 271(f)(1) requires at least two components to be supplied from the United States. Rejecting LifeTech's argument that more than one component must be supplied outside the United States, the Court held that "there are circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States." Id. at 27. The Court then considered the facts of the case, observing that there was evidence at trial that the Taq polymerase supplied by LifeTech was an essential component in the invention because it amplified the DNA sequences in order to obtain enough of the replicated sample for testing. The Court thus concluded that the evidence demonstrated that LifeTech supplied a substantial portion of the patented inventions—the polymerase—to its overseas facility as a component of the accused genetic testing kits, and held that there was substantial evidence in the record to support the jury's finding that LifeTech was liable for infringement under § 271(f)(1).

The Court then considered and reversed the district court's grant of LifeTech's motion for JMOL of direct noninfringement of the Tautz patent under § 271(a), concluding that there was substantial evidence produced at trial that some sales of the genetic testing kits in the United States infringed the Tautz patent under § 271(a).

Last, the Court affirmed the district court's determination that the field-of-use provision in the cross license limited LifeTech's use of the testing kits to "live" forensic investigations and did not cover sales of kits used for forensic research, training, and education at universities, and as part of other nonlaw enforcement bodies. Id. at 34 (citation omitted).

Accordingly, the Court reversed the district court's denial of SJ of invalidity for lack of enablement, reversed the district court's grant of JMOL of noninfringement of the Tautz patent under § 271(a) and (f)(1), affirmed the district court's finding that certain sales of LifeTech's kits were not covered by the cross license, vacated the jury's damages award, and remanded to determine the amount of damages for infringement of the Tautz patent.

Judge Prost dissented-in-part. Judge Prost disagreed with the majority and would have found that § 271(f)(1) requires inducement of another. Under this interpretation, Judge Prost would have found that LifeTech was not liable for infringement under § 271(f)(1).

Summary authored by Kumiko Kitaoka, Law Clerk at Finnegan.